MAUDE Adverse Event Report: BECKMAN COULTER AU5800 CLINICAL CHEMISTRY ANALYZER; ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Model Number AU5800-10

Device Problem Delivery System Failure (2905)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/06/2016

Event Type  malfunction  

Manufacturer Narrative

A beckman coulter (bec) field service engineer (fse) was dispatched to evaluate the instrument.The fse replaced the wash water valves (m271 valve assembly 6) on the outer ring of the customers au5800 clinical chemistry analyzer.The fse observed proper priming and washing at the cuvette wash station subsequently.The fse performed a photocal followed by the customer performing qc's.The analyzer was returned to the customer performing within specification.The internal beckman coulter identifier for this event is (b)(6).

Event Description

The customer reported the generation of an erroneously high magnesium patient result on their au5800 clinical chemistry analyzer.The result was not reported from the lab.There was no change in patient treatment.The initial result generated was lower than the repeat range which resulted in the customer retesting the sample.The repeat result recovered higher.The sample was retested for a third time and the result generated corresponded with the first result.The customer ran the same sample on another analyzer and the result corresponded with the initial result.The customer had performed quality control (qc) prior to and after the event and all were reported as being within specification.

• Brand Name: AU5800 CLINICAL CHEMISTRY ANALYZER
• Type of Device: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
• Manufacturer (Section D): BECKMAN COULTER; 250 s. kraemer blvd.; brea CA 92521
• Manufacturer (Section G): BECKMAN COULTER MISHIMA K.K.; 454-32 higashino; nagaizumi-cho; sunto-gun, shizuoka, jp-nota 411-0 931; JA 411-0931
• Manufacturer Contact: david davis ; 250 s. kraemer blvd; brea, CA 92821 ; 7149613796
• MDR Report Key: 5614424
• MDR Text Key: 43863805
• Report Number: 9612296-2016-00051
• Device Sequence Number: 1
• Product Code: JJE
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K112412
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AU5800-10
• Device Catalogue Number: B23279
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1